PENTAX EC38-i10L (UDI 04961333248209)Recalls & reported problems
Hoya Corporation · PENTAX VIDEO COLONOSCOPE EC38-i10 SERIES (Made in Malaysia) · Class 2
All models of PENTAX (72)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Pentax colonoscope is used to view the colon during procedures. Its 191 reports are mostly malfunctions, describing parts that detach, blocked or shadowed images, a blank or flickering display, and fluid or blood leaking into the scope. There are 5 injury reports, including some describing tears, and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 191
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 04961333248209), received between Jul 1, 2021 and Sep 18, 2026 — classified as 5 injuries, 186 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (60 reports).
6 other recalls cover devices cleared under the same FDA submission (K131855); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component60
- Optical Obstruction34
- No Display/Image33
- Fluid/Blood Leak21
- Erratic or Intermittent Display16
- Loose or Intermittent Connection5
- Obstruction of Flow5
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions187
- Laceration(s)4
Recent adverse event reports
The 25 most recent of 191 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Optical Obstruction
The time of event is unknown.There was no report of patient harm.Video image failure (Cloudy).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813599 ↗MalfunctionSep 3, 2026Fluid/Blood Leak
The time of event is unknown.There was no report of patient harm.Video image failure(Fluid damage).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50579749 ↗MalfunctionSep 1, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50536433 ↗MalfunctionAug 31, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515235 ↗MalfunctionAug 28, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50490890 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292697 ↗MalfunctionAug 17, 2026Optical Obstruction
The time of event is unknown. There was no report of patient harm. Video image failure(Shadow in image).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50269343 ↗MalfunctionAug 12, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217978 ↗MalfunctionAug 10, 2026No Display/Image
The time of event is unknown.There was no report of patient harm.Video image failure(Blackout ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50189581 ↗MalfunctionAug 10, 2026Erratic or Intermittent Display
The time of event is unknown.There was no report of patient harm.Video image failure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50189578 ↗MalfunctionJul 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50049574 ↗MalfunctionJul 21, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884952 ↗MalfunctionJul 17, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25851039 ↗MalfunctionJul 16, 2026Optical Obstruction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25834800 ↗MalfunctionJul 3, 2026Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25703732 ↗MalfunctionJun 18, 2026Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25542244 ↗MalfunctionJun 17, 2026No Display/Image
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25528134 ↗MalfunctionJun 16, 2026Erratic or Intermittent Display
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25514378 ↗MalfunctionJun 9, 2026Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25439751 ↗MalfunctionMay 22, 2026Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25251206 ↗MalfunctionMay 19, 2026Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25212145 ↗MalfunctionMay 18, 2026No Display/Image
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25197194 ↗MalfunctionMay 15, 2026No Display/Image
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179810 ↗MalfunctionMay 14, 2026Detachment of Device or Device Component
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25167873 ↗MalfunctionMay 8, 2026Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25120236 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131855. One submission often covers many models, so check the product and lot details in each record.
- Z-2448-2021 · Jul 14, 2021 · Open, ClassifiedColonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC
- Z-2449-2021 · Jul 14, 2021 · Open, ClassifiedGastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Chan
- Z-1267-2020 · Jan 3, 2020 · TerminatedPentax Video Colonoscope Model: EC34-i10L
- Z-1268-2020 · Jan 3, 2020 · TerminatedPentax Video Colonoscope Model: EC38-i10L
- Z-0636-2017 · Aug 15, 2016 · TerminatedPentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forcep
- Z-2068-2016 · Apr 6, 2016 · TerminatedColonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, ti
Other Colonoscope and accessories, flexible/rigid devices
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths6,804 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls5 deaths6,244 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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